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NCT05191472 · OUTCOME

Proportion of Participants With Reported Treatment-related Adverse Events

Pembrolizumab for the Treatment of Relapsed or Refractory Multiple Myeloma After Anti-BCMA CAR-T Therapies · Source last updated 2025-01-15

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
Up to 30 days after discontinuing study treatment, approximately 1 year and 8 months

What was measured

The safety population will consist of all participants who receive any amount of study treatment. Safety will be assessed by evaluation of AEs using the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Specific AEs will be counted once for each participant for calculating rates but will be presented in total in participant listings including frequency of non-hematologic grade 3 or higher adverse events.

Groups in this outcome

Treatment (Pembrolizumab)

Participants received pembrolizumab IV over 30 minutes on day 1. Cycles repeat every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Treatment (Pembrolizumab)3

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment (Pembrolizumab)0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0
denoms
  1. counts
    1. group Id
      OG000
      value
      3
    units
    Participants
description
The safety population will consist of all participants who receive any amount of study treatment. Safety will be assessed by evaluation of AEs using the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Specific AEs will be counted once for each participant for calculating rates but will be presented in total in participant listings including frequency of non-hematologic grade 3 or higher adverse events.
groups
  1. description
    Participants received pembrolizumab IV over 30 minutes on day 1. Cycles repeat every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity.
    id
    OG000
    title
    Treatment (Pembrolizumab)
param Type
COUNT_OF_PARTICIPANTS
reporting Status
POSTED
time Frame
Up to 30 days after discontinuing study treatment, approximately 1 year and 8 months
title
Proportion of Participants With Reported Treatment-related Adverse Events
type
SECONDARY
unit Of Measure
Participants

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice